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In order to determine the quality of TSUMURA Shuchi-Bushi Powder N (TJ-3022) which is a herbal drug processed by autoclaving Aconiti tuber (Aconitum carmichaeli DEBX.), we investigated the seasonal variations of aconitine alkaloids in the raw aconiti tubers cultivated for 4 years in Iwate Prefecture and examined both acute toxicities and analgesic effects of the processed aconiti tubers prepared in different process conditions. The raw tubers harvested from September to October were high and stable in the contents of aconitine alkaloids.The LD_<50> values of mesaconitine,raw tubers and processed tubers (autoclaved at 105℃ for 10-50 min) were 5.64 mg/kg(p.o.), 3.03g/kg(p.o.) and >10g/kg(p.o.), respectively. The analgesic effect of the processed tuber autoclaved at 105℃ for 50min at a dose of 500mg/kg (p.o.) was almost equal to that of mesaconitine at a dose of 0.05mg/kg (p.o.). On the basis of the present results, the quality of TJ-3022 was standardized for ethical dispensing. By tail pressure method in normal and repeated cold stress mice, the ED_<50> values of TJ-3022 were 170.1mg/kg(p.o.) and 92.9mg/kg(p.o.), respectively. Moreover, antinociceptive effects of TJ-3022 were noted in acetic acid-induced writhing test, Randall-Selitto's test, adjuvant-induced arthritic pain and tail-flick test. Its safety margin (=LD_<50>/ED_<50>) was estimated to be 5-18 times that of mesaconitine.